Kornimate/medical-research-clean huggingface dataset:
does prehabilitation improve exercise performance and insulin resistance after surgery for oesophago-gastric cancer?

Conditions: Cancer

Summary: the purpose of this study is to evaluate the effect of a multimodal pre-operative prehabilitation programme during neo-adjuvant therapy on cardiopulmonary exercise performance and insulin resistance prior to resection for oesophago-gastric cancer.

the trial objectives are as follows: primary: to evaluate the effect of a prehabilitation programme during neo-adjuvant therapy on cpx performance prior to resection for oesophago-gastric cancer. secondary: to investigate the impact of neo-adjuvant chemotherapy on insulin resistance; to determine whether a prehabilitation exercise programme is feasible during neo-adjuvant chemotherapy; to determine whether rehabilitation has a positive impact on quality of life outcomes; to investigate the impact of prehabilitation on clinical outcomes; to assess the effect of prehabilitation on nutritional status; to determine whether prehabilitation affects the stress response to surgery. this study is a randomised controlled trial where patients will be stratified into 'fit' and 'unfit' groups based upon their anaerobic threshold and then randomised in a 1:1 ratio to receive multimodal prehabilitation or standard care prior to og cancer surgery, during neo-adjuvant chemotherapy.

Eligibility criteria:
inclusion criteria: * patients listed for elective oesophagectomy or total gastrectomy for cancer * must have capacity to consent * age 18-99 exclusion criteria: * known contraindication for cpx * physically unable to perform cpx test or undertake prehabilitation exercise programme * pregnant patients or those planning to become pregnant * lack of capacity to give informed consent

Keywords: prehabilitation oesophago-gastric cancer neo-adjuvant exercise cardiopulmonary exercise test insulin resistance
full4health: understanding food-gut-brain axis across the lifecourse

Conditions: Obesity

Summary: the primary aim of this work is, to 'relate psychological and behavioural parameters of hunger/satiety and food preference to gut hormones, neural activation and energy metabolism by dietary manipulation, across the human lifespan'.

the full4health project aims to further understanding of the mechanisms of hunger and satiety. the proposal integrates investigation of human volunteers and laboratory rodents throughout the life course, applying imaging and other cutting edge technologies to critical research questions. full4health will combine study of the mechanisms of hunger and satiety with intervention studies to validate the effects of the relevant food characteristics on the regulation of satiety/hunger. the development of cerebral responses to food through the gut-brain axis across lifespan particularly during childhood, adolescence and elderly will be studied.

Eligibility criteria:
inclusion criteria: * willingness to participate in the fmri study * right-handed * not heavy smokers (less 10 day) * mri compatibility: * no claustrophobia * no metal in the body (including dental braces) exclusion criteria: * heavy smokers (more than 10/day) * morbid obese (bmi\>40 kg/m2) * pregnancy * obesity of known endocrine origin * neurological disorders including cerebral palsy * alzheimers disease * multiple sclerosis * parkinsons disease * medication known to influence appetite (orlistat, oral antidiabetics, insulin, digoxin, anti-arrhythmics, sibutramine, antidepressants) * self report fever/systemic infection * inability to participate in fmri scanning sessions including contraindications to mri * participation in medical or surgical weight loss programme within 1 month of selection * history of cerebrovascular disease * current major depressive disorder, bipolar disorder or past history of suicide attempt or self harm * history of drug or alcohol misuse * history of significant cardiovascular disease * allergy to any of the breakfasts components.

Keywords: appetite food gut brain satiety hunger gut hormones
study to compare the safety of immediate one-stage ibbr with expander-implant two-stage ibbr augmented with tiloop® bra(costa)

Conditions: Breast Cancer

Summary: this study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage ibbr compared with those of two-stage ibbr with tiloop® bra.

studies comparing two-stage implant-based breast reconstruction with immediate one-stage implant-based breast reconstruction have inconsistent results and investigators find that there is a lack of high quality evidence focusing on comparing one-stage and two-stage implant-based breast reconstruction with tiloop®bra. this study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage ibbr compared with those of two-stage ibbr with tiloop® bra in breast cancer patients. the hypothesis is that one step method is not inferior to two step method in implant based breast reconstruction following skin-sparing and/or nipple-sparing mastectomy using tiloop® bra. the current study is a randomized multicenter, open labeled, prospective, controlled study. participants were enrolled at six hospitals in different places of china. all participants will undergo skin sparing mastectomy(ssm)/nipple sparing mastectomy(nsm) with one-stage or two stage ibbr with tiloop® bra. based on earlier experience, investigators calculated that the surgical complication rate was approximately 30 percent in the one-stage group and 25 percent in the two-stage group. consider a dropout rate of 5%, a total of 450 patients, with 225 in each group, are needed.

Eligibility criteria:
inclusion criteria: * patients with histological proven invasive breast cancer or ductal carcinoma in situ; * clinical t1-t2 disease with no distant metastasis; * patient with clinical n0 status; * intent to receive nsm or ssm and implant based breast reconstruction; * signed consent to participate. exclusion criteria: * patient with severe breast ptosis; * patient received ipsilateral breast reduction or enlargement; * locally advanced stage patients who received neoadjuvant chemotherapy or hormone therapy; * patients enrolled in other clinical trial which may as influence the outcome; * patients received neo-adjuvant therapy and will receive radiotherapy. * history of breast cancer (ipsilateral, i.e. recurrence, or contralateral breast); * patients of pregnancy or lactation.

Keywords: immediate implant reconstruction tiloop® bra
a study to describe a group of spanish patients with fmf and to identify suboptimally treated patients with minimal disease activity and its impact on quality of life

Conditions: Familial Mediterranean Fever

Summary: a retrospective, non-interventional, single-center study conducted in spain, based on the collection of data from the medical histories of patients with familial mediterranean fever (fmf) diagnosed during childhood from january 2005 to december 2021. data from the patients' medical records was collected retrospectively, from the time of diagnosis to the current moment of the patient's enrollment in the study. patients had a minimum follow-up of 3 months after diagnosis.


Eligibility criteria:
inclusion criteria: 1. patients with fmf clinically and/or genetically diagnosed during childhood according to the site's clinical practice. 2. patients with at least 3 months of follow-up from the date of diagnosis, at the time of their enrollment in the study. exclusion criteria: 1. patients with autoinflammatory disease excluding fmf. 2. patients with recurrent fever of another etiology (infectious, tumor or other).
restoring arm and hand function with non-invasive spinal stimulation

Conditions: Paralysis; Spinal Cord Injury

Summary: this study is to determine if non-invasive electrical stimulation of the spinal cord can help improve hand and arm function in people with paralysis who suffered a cervical spinal cord injury.

this study is to determine if non-invasive electrical stimulation of the spinal cord can help improve hand and arm function in people with paralysis who suffered a cervical spinal cord injury. the investigators hypothesize that this stimulation can revive spared function in the spinal cord of individuals who are clinically paralyzed, but who have some remaining connections between the brain and spinal cord. our research has demonstrated that modifying the activation state of the spinal cord or awakening the spinal cord can benefit people with paralysis years after a spinal cord injury. this method and device have not yet been approved by the fda for the treatment of paralysis and are under investigation. this study if successful will help provide further evidence that could be use to gain fda approval.

Eligibility criteria:
inclusion criteria: asia c * spinal cord injury 1 or more years prior * non progressive sci at c7 or higher * half of key muscles below neurological level having a motor score of less than 2/5 * ability to commit to home exercises and 12 week participation * stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in upper extremity rehabilitation or testing activities * not dependent on ventilation support * no painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or urinary tract infection that might interfere with upper extremity rehabilitation or testing activities * no clinically significant depression or ongoing drug abuse * adequate social support network to be able to participate in weekly training and assessment sessions for the duration of the 12 week study period * no current anti-spasticity regimen * must not have received botox injections in the prior six months * be unable to use upper extremity for functional tasks exclusion criteria: * pregnancy * no functional segmental reflexes below the lesion

Keywords: spinal cord injury quadriplegia tetraplegia stimulation
efficacy and safety of tacs vs tdcs in schizophrenia

Conditions: Schizophrenia

Summary: this clinical trial aims to compare the efficacy and safety of transcranial alternating current stimulation (tacs) vs. transcranial direct current stimulation (tdcs) vs. sham stimulation in chronic schizophrenia. the main question it aims to answer is: • in comparison to tdcs, can tacs improve the clinical outcome of patients with chronic schizophrenia? participants will be randomised into 3 groups receiving either tdcs, tacs or sham stimulation and changes in psychopathology and neuro-cognition with the interventions will be compared within and between the groups. the primary outcome measure is the positive and negative syndrome scale (panss), while secondary outcome measures are the auditory hallucination rating scale (ahrs), brief cognitive assessment tool for schizophrenia (b-cats), and global assessment of functioning (gaf).

the proposed double-blind rct will be conducted over 3 years involving 2 centres among patients with chronic schizophrenia (moderate-severe symptoms) of either gender, aged between 18 and 60. those with any psychiatric emergency or contraindications for tdcs will be excluded. at baseline, panss will be administered to assess the severity of symptom dimension, ahrs for auditory hallucinations, b-cats for neurocognitive deficits and gaf for global functionality. patients will be randomized equally to 3 treatment groups: tacs, tdcs, or sham stimulation (30 in each group). the intervention will involve cathodal stimulation of left tpj and anodal stimulation of left dlpfc. the transcranial brain stimulations: tacs, tdcs, or sham stimulation, will be given 2 sessions per day for 10 days. following the 5th day and after the last treatment session, panss, ahrs, b-cats, and gaf will be readministered to observe for the changes in the various outcome parameters. any new treatment-emergent serious adverse effect will be recorded.

Eligibility criteria:
inclusion criteria: 1. diagnosis of schizophrenia as per icd-10 dcr for more than 2 years 2. moderate-severe symptoms (panss score \> 75 and/or cgi-sch score\>4) \[24\] 3. on stable dosing of antipsychotic medications (no changes in medication or doses for 1 month prior to enrolment) 4. both sexes; age range: 18-60 years 5. right-handed 6. written informed consent by the patient exclusion criteria: 1. features suggestive of psychiatric emergency (for example: suicidal risk, catatonia, prolonged nutritional deprivation) or others (for example: aggression or excitement) 2. any contraindication to tdcs procedure: metal in the head, implanted brain medical devices, local lesion or injury in the scalp / head 3. co-morbid neurological disease 4. left handed
transcutaneous diaphragm electrical stimulation in critically ill patients

Conditions: Critical Illness; Mechanical Ventilation; Intensive Care Unit

Summary: this study evaluates the effect of a transcutaneous electrical stimulation in critically ill patients compared to a sham electrical stimulation to decrease the incidence of diaphragm dysfunction before mechanical ventilation weaning.


Eligibility criteria:
inclusion criteria: * patients intubated and ventilated for at least 24 h * patients who were expected to have at least 48h after inclusion exclusion criteria: * patient with pacemaker * patient under neuro muscular blocker * patient post thoracic or abdominal surgery * patient with bmi more than 35 kg/m² * patient with degenerative neurological pathology * patient with cutaneous lesion may be interfered with probes * patient with chronic loss of autonomy * patient hospitalized more than 72 hours before icu admission * patient with severe chronic obstructive pulmonary disease (fev1 \< 30%) * patient with decision to withhold life-sustaining treatment

Keywords: diaphragm dysfunction transcutaneous electrical stimulation intensive care unit mechanical ventilation
mtorc1 and autophagy in human brown adipocytes

Conditions: Obesity; Metabolic Disease

Summary: the long term goal is to identify the potential therapeutic targets for the treatment of obesity and its associated disorders by studying the driving factors of activation of brown adipose tissue (bat) in human adults. whereas activation of brown adipose tissue (bat) in human adults has been considered as a potential therapeutic target to battle obesity since it was identified in 2009, the underlying mechanisms of beige adipocytes appearance in human adults is unclear. the objective of this proposal is to investigate the role of autophagy in mediating the inhibitory effect of mammalian target of rapamycin complex 1 (mtorc1) in regulating human brown adipocytes. the central hypothesis is that autophagy plays a critical role in regulating browning of white adipose tissue and mediates the beneficial effect of mtorc1 inhibition on thermogenesis in human brown adipocytes.

specific aim 1: to investigate the role of mtorc1 and autophagy in regulating thermogenesis in human brown adipocytes. the working hypothesis is that inhibition of mtorc1 or activation of autophagy improves thermogenesis in human brown adipocytes. it will be first determined if the mtorc1/autophagy signaling modulates thermogenic gene expression and beige markers by collecting human brown fat from lean non-diabetic subjects. the brown fat during the anterior cervical spine surgery or thyroidectomy from lean subjects with a bmi \ 30, will be harvested and then be used to determine: 1) whether mtorc1 signaling, autophagy and thermogenic gene expression, and the fraction of various types of immune cells in human brown fat are different from those in rodents;2) whether rapamycin treatment enhances basal or cl-induced thermogenic gene expression and o2 consumption in primary human brown adipocytes; and 3) whether inhibition of autophagy by 3-methyladenine (3-ma) suppresses thermogenic gene expression induced by cl316,243, a β3-adrenoceptor agonist that mimics cold stress in vivo in human brown adipocytes. overall, this study will lead to the identification of mtorc1 as a key regulator of thermogenesis in human adipose tissue and reveal promising new anti-obesity drug targets. in addition, this study will further investigate the role of rapamycin administration in obesity in human adults near the future. these studies are designed to be a proof-of-principle. if the results are promising, then future drug development could focus on designing new inhibitors of mtorc1.

Eligibility criteria:
inclusion criteria: * male or female * age 18-60 * able to give informed consent * non-diabetic * scheduled for anterior cervical spine, thyroidectomy, or parathyroidectomy surgery at unmhsc * bmi \ 30 (obese) * english or spanish speaking exclusion criteria: * has diabetes mellitus (type i or ii) * currently on any study medication (including sedatives or analgesics, coagulopathy (inr of 1.5 or greater, platelet count of \<50,000/microliter), or anticoagulant) * pregnant * incarcerated

Keywords: autophagy inflammation metabolism adipocyte mtorc1 obesity thermogenesis
optical coherence tomography angiography and choroidal osteoma

Conditions: Choroidal Osteoma, Bilateral

Summary: this study evaluates the vessel density of choriocapillary vascular network in eyes affected by choroidal osteoma and in eyes complicated by choroidal neovascularization, using optical coherence tomography angiography.

the choroidal osteoma is a rare benign tumor of choroid, it is bilateral in 10%-25% of cases, affecting usually young women. previous studies evaluated the morphologic characteristics of tumor-related vasculatures, described as a seafun vascular networks, but none focused on study of vessel density of coriocapillary. the aim of this study is to investigate the potential role of the optical coherence tomography angiography (octa) in evaluating the choriocapillary vessel density in order to individuate the changes of this vascular network that may influence the onset of choroidal neovasculariztion. therefore, octa could be useful in the clinical management of the choroidal osteoma

Eligibility criteria:
inclusion criteria: * age older than 50 years * diagnosis of choroidal osteoma * absence of history of vitreoretinal and vascular retinal diseases exclusion criteria: * age younger than 50 years * no diagnosis of choroidal osteoma * presence of history of vitreoretinal and vascular retinal diseases
food matrix and genetic variability as determinants of bioavailability and biological effects of beta-cryptoxanthin and phytosterols

Conditions: Hypercholesterolemia; Osteoporosis

Summary: regular consumption of a beverage containing β-cryptoxanthin (b-cx) and plant sterols (ps) has been shown to exert a synergic effect in reducing cardiovascular risk and bone remodeling markers (formation and resorption). the present project aims to assess the influence of technological treatment and genetic variability on the bioavailability and the health effects of the added components (ps, b-cx), in particular to their potential role in prevalent disorders.in vitro and in vivo studies will be carried out to this effect. in vitro and in vivo studies (human intervention study) will be performed and cardiovascular, bone turnover and inflammation markers will be evaluated. additionally, an in vitro colonic fermentation model and cell cultures will be used to explore anticarcinogenic effects and potential cytotoxicity.


Eligibility criteria:
inclusion criteria: * post-menopausal women; mild hypercholesterolemia exclusion criteria: * use of cholesterol lowering drugs, hormonal therapy, vitamin and herbs supplements use

Keywords: b-cryptoxanthin plant sterols serum cholesterol bone turnover markers
s9809, ciprofloxacin compared with cephalexin in treating patients with bladder cancer

Conditions: Bladder Cancer

Summary: rationale: chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. it is not yet known whether ciprofloxacin is more effective than cephalexin in preventing cancer recurrence in patients who are undergoing surgery to treat bladder cancer. purpose: randomized phase iii trial to compare the effectiveness of ciprofloxacin with that of cephalexin in preventing recurrence of cancer in patients who are undergoing surgery for bladder cancer.

objectives: i. determine whether ciprofloxacin improves the recurrence-free survival of patients with superficial transitional cell carcinoma of the bladder treated with a transurethral tumor resection. outline: this is a randomized, multicenter study. patients are stratified according to disease status (first occurrence vs recurrent disease). patients are randomized to receive either oral ciprofloxacin or oral cephalexin 2 times a day for 3 days starting the night before resection. patients who are allergic to penicillin or a cephalosporin receive oral co-trimoxazole 2 times a day for 3 days. all patients undergo complete resection of all bladder tumors. patients are followed every 3 months for the first 2 years, every 6 months for the next 2 years, and at the end of the fifth year. projected accrual: a total of 900 patients will be accrued for this study over 3 years.

Eligibility criteria:
disease characteristics: stage ta (any grade) transitional cell carcinoma of the bladder on basis of cystoscopy recurrent disease no greater than t1 must not be at high risk for upper tract (ureter or renal pelvic) transitional cell cancers patient characteristics: age: 18 and over performance status: swog 0-2 life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: not pregnant or nursing fertile patients must use effective contraception no other prior malignancy in the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage i or ii cancer in complete remission no allergies to fluoroquinolones if allergic to penicillin or cephalosporin, must be able to take co-trimoxazole prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 28 days since prior intravesical therapy and recovered endocrine therapy: not specified radiotherapy: at least 28 days since prior radiotherapy and recovered surgery: not specified other: at least 3 months prior to cystoscopy since prior fluoroquinolones no concurrent fluoroquinolones no concurrent hemodialysis or peritoneal dialysis no concurrent probenecid or theophylline no concurrent antacids containing aluminum, magnesium or calcium, products containing iron or zinc, caffeine, cyclosporine, or warfarin

Keywords: stage 0 bladder cancer recurrent bladder cancer transitional cell carcinoma of the bladder
comparison of a face cream plus a laser procedure and face cream alone in treatment of excessive face hairs in female

Conditions: Hirsuitism

Summary: the study compares the effects of a cream alone and a combined effect of cream and laser for the treatment of excessive facial hairs in women .

hirsuitism refers to excessive terminal hairs in females, following a distribution pattern typically associated with male. it is associated with either increase response of hair follicles to androgen or either increase level of circulating androgens.the treatment options available are topical creams like eflornithine and laser treatments for hair removal. this study aims to conduct the comparison of a eflornithine cream and intense pulsed light laser versus eflornithine cream alone for the treatment of excessive facial hairs.

Eligibility criteria:
inclusion criteria: gender (female) age between 18-45 years women with hirsutism as mentioned in the operational definition exclusion criteria: pregnant women women with severe acne women with immunodeficiency

Keywords: hirsuitism ipl eflornithine